Any healthcare systems during a pandemic undergo tremendous pressure in pursuit of effective treatment to treat and limit the spread of the disease and its implications. Conducting clinical trials to find the potential therapy is the only way to battle the current coronavirus disease-2019 pandemic. The majority of the countries have joined the cause and are carrying out clinical studies in various capacities. As a result, the ethical committees have encountered a sudden inflow of a large number of (...) trial proposals that have placed them under pressure. Although ethical committees play a vital role in protecting patient safety and preserving research integrity, they need to make sure the efficiency and integrity of review are preserved and the standards of review are not relaxed. Thus, the participants’ dignity is well guarded while keeping a close check on their safety. (shrink)

There is a gap in the clinical bioethics literature concerning the approach to assessment of medical decision-making capacity of adolescents or young adults who demonstrate diminished maturity due to longstanding reliance on caregiver support, despite having reached the age of majority. This paper attempts to address this question via the examination of a particular case involving assessment of the decision-making capacity of a young adult pregnant patient who also had a physically disabling neurological condition. Drawing on concepts (...) from adolescent bioethics and feminist critiques of bioethical theory, we argue that limited life experience, secondary to a disabling neurological condition, can result in a lack of adult-like capacity even in a patient who is legally an adult. In such cases, it may be that autonomy, to the extent that it is to be relevant and meaningful, must be viewed through a relational lens. Furthermore, clinicians may avoid unjustifiably paternalistic practices by working with the patient help her gain a better appreciation of the consequences of her decision, thereby calling forward her capacity rather than resorting to being directive in counseling. We conclude that lessons from this case can be used to approach ethically complex instances of medical decision-making in adult patients with normal cognition but diminished experiential maturity. (shrink)

In this article, we explore alternative conflict resolution strategies to assist families and clinicians in cases of intractable dissent in paediatric health care decision-making. We focus on the ethical and legal landscape using cases from the Australian jurisdiction in New South Wales, while referencing some global sentinel cases. We highlight a range of alternative means of addressing conflict, including clinical ethics support, and contrast and contextualise facilitative or interest-based mediation, concluding that legal intervention via the courts (...) can be protracted and distressing and should be a ‘last resort’. We acknowledge many might view this as the current status quo, but we go further to recommend strategies optimal for all parties to recognise early signs of conflict and prevent its harmful escalation. While more empirical research is needed, we contend that interest-based mediation may be a valuable adjunctive method of conflict resolution. If judiciously distinguished from and utilised with clinical ethical support, it can be an effective tool to address dissent and its negative sequelae in paediatric healthcare decision-making. (shrink)

Background This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from (...) research interviews and observations in two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery. Results The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices. Conclusion We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights. (shrink)

Background This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from (...) research interviews and observations in two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery. Results The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices. Conclusion We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights. (shrink)

The necessity of consent is widely justified on the basis of the principle of respect for autonomy. Also, it is widely believed that shared decision making (SDM) is the practical device to seek patients’ consent for medical treatment. In this essay, I argue that SDM, while necessary, is insufficient for consent; because, in the paradigm of evidence-based medicine, SDM is contingent upon other practices to identify appropriate treatments that form the subjects of SDM. Indeed, case law emphasises normative decision-making (...) practices that precede SDM. Furthermore, case law supplies a nuanced understanding of SDM, which includes not only exchange of information but also attention to human vulnerability that persists despite formal retention of decision-making capacity. In addition, the law marks out a space in which people with capacity are absolutely entitled to self-determination. Thus, a four-step framework of decision making can be induced from legal doctrine. This legal framework corresponds to a construct of respect for autonomy that draws upon feminist theory. Feminist scholars have objected to the focus on individuals in traditional theories of autonomy; instead, they insist that people have to be considered in the context of their social influences and relationships. Feminists separate out four ideas of autonomy, and these ideas can be used to construct a four-layered model of respect for autonomy, in which each layer corresponds sequentially to a step in the legal framework of decision making. This model of respect for autonomy provides both conceptual clarity and theoretically robust justification for doctors’ various obligations in decision-making practices for consent. (shrink)

The decision of the High Court in Bell v Tavistock has excited considerable discussion about lawful consent for puberty-blocking drug treatment for children with gender dysphoria. The present paper draws attention to a wider question that surfaces through this case: is informed decision-making an adequate practical tool for seeking and obtaining patients’ consent for medical treatment? Informed decision-making engages the premises of the rational choice theory: that people will have well-crystallised health goals; and, if they are provided with sufficient (...) information about medical treatments, then they will be able to choose the treatment that satisfies their goals. Whilst appealing, the informed decision-making paradigm is assailed by various fallacies, which apply not only to children but also to adults. In Bell v Tavistock, the High Court seems to have recognised such fallacies, and it rejected informed decision-making as an adequate tool for consent from children with gender dysphoria. Similar considerations apply to adults in various situations. Thus, Bell v Tavistock can be seen as an attempt to refine the views on the consent that were expressed by the Supreme Court in Montgomery. It can be inferred that the Supreme Court did recognise the limitations of informed decision-making, but it did not develop this point. Further work is required to formulate an adequate model of decision-making, and Bell v Tavistock serves as a useful reminder to rethink informed decision-making as the device for consent. (shrink)

Like other Arab countries, Jordan must find ways of responding to the rapid processes of change affecting many aspects of social life. This is particularly urgent in healthcare, where social and technical change is often manifested in tensions about ethical decision-making in the clinic. To explore the attitudes, beliefs and concerns relating to ethical decision-making among health professionals in Jordanian hospitals, a qualitative study was conducted involving face-to-face interviews with medical personnel in four hospitals in Amman, the capital (...) of Jordan. Data were analysed thematically in relation to a pre-existing set of ethical categories. Interviews were conducted with thirty-eight doctors covering most medical specialities. Five major themes emerged from the interviews: ethical awareness, ethical issues, the impact of religion on ethical decision-making, practical and theoretical resources for ethical decision-making, and challenges. While uncertainty was expressed about some aspects of Western approaches to ethics, participants strongly supported adoption of a range of Western bioethical principles, including cultural and ethical diversity, along with adherence to Islamic religious norms. A range of serious ethical challenges facing the Jordanian health system were identified, covering social, legal, managerial, and technical issues. Ethical decision-making in Jordan is complex, having to accommodate the needs of patients, the opinions of doctors and their families, the views of religious authorities, managerial considerations, and both local norms and international standards. Health professionals struggle with three sets of tensions that emerge out of the struggle between traditional, community-embedded forms of social organization and the demands generated by globalization and the influence of Western culture: the tensions between tradition and modernity, conservatism and pragmatism, and religion and secularism. Doctors in Jordan prefer approaches to ethical decision-making that realize a balance between the extremes, although the exact nature of where that balance should lie remains uncertain. (shrink)

Clinical ethics records offer bioethics researchers a rich source of cases that clinicians have identified as ethically complex. In this paper, we suggest that clinical ethics records can be used to point to types of cases that lack attention in the current bioethics literature, identifying new areas in need of more detailed bioethical work. We conducted an analysis of the clinical ethics records of one paediatric hospital in Australia, focusing specifically on conflicts (...) between parents and health professionals about a child’s medical treatment. We identified, analysed, and compared cases of this type from the clinical ethics records with cases of this type discussed in bioethics journals. While the cases from journals tended to describe situations involving imminent risk to the child’s life, a significant proportion of the clinical ethics records cases involved different stakes for the child involved. These included distress, poorer functional outcome, poorer psychosocial outcome, or increased risk of surgical complications. Our analysis suggests that one type of case that warrants more detailed ethics research is parental refusal of recommended treatment, where the refusal does not endanger the child’s life but rather some other aspect of the child’s well-being. (shrink)

Up to the present, there have not been any specific norms regarding medically assisted human reproduction in Romanian legislation. Due to this situation the general legislation regarding medical assistance, the Penal and Civil law and the provisions of the Code of Deontology of the Romanian College of Physicians are applied to the field of medically assisted human reproduction. By analysing the ethical and legal conflicts regarding medically assisted human reproduction in Romania, some characteristics cannot be set apart because (...) they derive from religious, cultural and socio-economic aspects. In this article the authors identify the development stages of medically assisted human reproduction in Romania, beginning from these characteristics and insisting upon the failure of the legal system in this specific field. The authors consider that the law regarding medically assisted human reproduction cannot be effective because it did not take into account the ethical and cultural aspects that might appear. Furthermore, in this framework of the legal process, no public debate involving the representatives of civil society was undertaken although the Council of Europe Oviedo Convention approved by our country according to law no. 17/2001 stipulated exactly this working method. Content Type Journal Article Pages 4-13 Authors Beatrice Ioan, PHD, MD, MA IN BIOETHICS, University of Medicine and Pharmacy, Iasi, Romania Vasile Astarastoae, PHD, MD, JD, University of Medicine and Pharmacy, Iasi, Romania Journal Human Reproduction & Genetic Ethics Online ISSN 2043-0469 Print ISSN 1028-7825 Journal Volume Volume 14 Journal Issue Volume 14, Number 2 / 2008. (shrink)

Background The nursing profession requires ethical and legal regulations to guide nurses’ performance. Ethical climate plays a part in shaping nurses’ ethical practice. Therefore, ethico-legal aspects and ethical climate contribute to improving nurses’ ethical practice and competencies with reducing medical errors in hospital settings. Objective This study examined the effect of ethico-legal aspects and ethical climate on managing safe patient care and medical errors among nurses. Materials and methods A cross-sectional correlational study was (...) carried out on 548 nurses. Data were collected through self-administered questionnaires about nurses’ knowledge in both ethical and legal aspects, ethical practice, competencies, ethical climate and experience with medical error. Results The main sources of nurses’ knowledge of ethical and legal aspects were undergraduate lectures, job experience and colleagues. Nurses’ knowledge in both ethical and legal aspects, nurses’ ethical practice and competencies were insufficient. Nurses fairly perceived their ethical climate. Also, nurses experienced medical errors about 22.6% in their units. Nurses’ knowledge of ethical and legal aspects, as well as the ethical climate were positive predictors of inadequate nurses’ ethical practice and competencies. Additionally, nurses’ knowledge in both ethical and legal aspects, ethical climate and practice had a negative influence on the occurrence of medical errors. Conclusion Enhancing nurses’ knowledge in both ethical and legal aspects as well as ethical climate could significantly influence improving nurses’ ethical practice, competencies and reducing medical errors in the study units. Therefore, planning for enhancing the nurses’ ethico-legal learning and ethical climate seems to be mandatory. (shrink)

In an increasingly litigious society where ritual demands for accountability and “taking responsibility” are now commonplace, it is not surprising that members of clinical ethics committees (CECs) are becoming more aware of their potential legal liability. Yet the vulnerability of committee members to legal action is difficult to assess with any certainty. This is because the CECs which have been set up in the UK are—if the American experience is followed—likely to vary significantly in terms of (...) their functions, procedures, composition, structures and authority. As a consequence it is difficult to generalise about the legal implications. Nevertheless, despite these difficulties this article will outline the broad legal principles governing the potential liability of committee members. It will also consider the relationship between CECs and the courts. It begins, however, with a brief analysis of the relationship between ethics and law in committee deliberations, and in particular of the role of law and legal expertise on CECs. (shrink)

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

Advances in medical technology and information have facilitated clinical practices that favourably affect the success rates of treatment for diseases. Regenerative medicine has been the focus of the recent medical agenda, to the extent of fundamentally changing treatment paradigms. Stem cell practices, their efficacy, and associated ethical concerns have been debated intensively in many countries. Stem cell research is carried out along with the treatment of patients. Thus, various groups affected by the practices inevitably participate in the (...) discussions. In addition to discussions based on avoiding any harm, providing benefits and respecting personal autonomy and justice, problems arise owing to the lack of legal regulations for stem cell research and practice. The dimensions of the problems vary in the developing countries, with widespread use of advanced medical technology but with lack of sources allocated for healthcare, dominance of paternalistic physician–patient relationships and failure to achieve a sufficient level of awareness of patients’ rights. This article discusses the current situation of stem cell practices within the context of regenerative medicine in Turkey and ethical concerns about some of the legal regulations, such as the Regulation for Umblical Cord Blood Banking and Guidelines for Non-embryonic Stem Cell Study for Non-clinical Purposes directing the research on this issue. (shrink)

This essay examines the so-called phenomenon of defensive medicine and the problematic aspects of attempting to maintain the safest legal position possible. While physicians face genuine litigation threats they frequently overestimate legal peril. Many defensive practices are benign, but others alter patient care and increase costs in ways that are ethically suspect. Physicians should learn to evaluate realistically the legal risks of their profession and weigh the emotional, physical, and financial costs to the patient before employing (...) a defensive measure. (shrink)

The Direction of Medical Ethics The direction bioethics, and specifically medical ethics, will take in the next few years will be crucial. It is an emerging specialty that has attempted a great deal, that has many differing agendas, and that has its own identity crisis. Is it a subspecialty of clinical medicine? Is it a medical reform movement? Is it a consumer pro tection movement? Is it a branch of professional ethics? Is (...) it a ra tionale for legal decisions and agency regulations? Is it something physicians and ethical theorists do constructively together? Or is it a morally concentrated attack on high technology, with the prac titioners of scientific medicine and the medical ethicists in an adversarial role? Is it a conservative endeavor, exhibiting a Frankenstein syn drome in Medical Genetics ("this time, they have gone too far"), or a Clockwork Orange syndrome in Psychotherapy ("we have met hods to make you talk-walk-cry-kill")? Or does it suffer the afflic tion of overdependency on the informal fallacy of the Slippery Slope ("one step down this hill and we will never be able to stop") that remains an informal fallacy no matter how frequently it's used? Is it a restricted endeavor of analytic philosophy: what is the meaning of "disease," how is "justice" used in the allocation of medical resources, what constitutes "informed" or "consent?" Is it applied ethics, leading in clinical practice to some recommenda tion for therapeutic or preventive action? This incomplete list of questions indicates just how complex. (shrink)

In 1972, I created the new field of clinical medical ethics (CME) in the Department of Medicine at the University of Chicago. In my view, CME is an intrinsic part of medicine and is not a branch of bioethics or philosophical ethics or legal ethics. The relationship of patients with medically trained and licensed clinicians is at the very heart of CME. CME must be practiced and applied not by nonclinical bioethicists, but rather (...) by licensed clinicians in their routine, daily encounters with inpatients and outpatients. CME addresses many clinical issues such as truth-telling, informed consent, confidentiality, surrogate decision making, and end-of-life care, while also encouraging personal, humane, and compassionate interactions between experienced clinicians and patients.The goals of CME are to improve patient care and outcomes by helping physicians and other health professionals Clinical Medical Ethics: Its History and Contributions to American Medicine Mark Siegler, Guest Editor identify and respond to clinical-ethical challenges that arise in the ordinary care of patients. As Edmund Pellegrino, Peter A. Singer, and I wrote in the first issue of The Journal of Clinical Ethics, 30 years ago: “The central goal of CME is to improve the quality of patient care by identifying, analyzing, and contributing to the resolution of ethical problems that arise in the routine practice of clinical medicine.” Similar to cardiology and oncology consultations, ethics consultations are a small component of a much larger field, and the process of consultations is certainly not at the core of cardiology or oncology or CME.In this article, I intend to discuss the origins of the field of CME, its goals and methods, the relationship between the broad field of CME and the much narrower practice of ethics consultation, the contributions of the MacLean Center at the University of Chicago in developing the field of CME, and, finally, how CME has improved the practice of medicine in the United States. (shrink)

This book discusses feature films that enrich our understanding of doctor-patient dilemmas. The book comprises general clinical ethics themes and principles and is written in accessible language. Each theme is discussed and illuminated in chapters devoted to a particular film. Chapters start with a discussion of the film itself, which shares details behind the making of the film; critical reception; casting and other facts about production. The chapter situates the film in a history of medicine and medical (...) sociology context, analyzes ethical issues raised in the film from a clinical ethics lens, and explains to readers how to use each film as a teaching aid for clinical ethics. Readers will understand how each film in this collection served to bring particular clinical ethics issues to the public’s attention, or reflected medico-legal issues that were part of the public discourse. The book is a perfect instructor's guide for anyone teaching bioethics, healthcare ethics, medical sociology, medical history, healthcare systems narrative medicine, or nursing ethics. (shrink)

Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have (...) been analyzed under the following aspects: mode of establishment of HECs, character of consultation they provide, and their composition. The results show that HECs in the transition countries of Central and Eastern Europe differ from their western-European or U.S. counterparts with regard to these three aspects. HECs were established because of centrally imposed legal regulations. Little initiatives in this area were taken by medical professionals interested in resolving emerging ethical issues. HECs in the transition countries concentrate mostly on review of research protocols or resolution of administrative conflicts in healthcare institutions. Moreover, integration of non-professional third parties in the workings of HECs is often neglected. We argue that these differences can be attributed to the historical background and the role of medicine in these countries under the communist regime. Political and organizational structures of healthcare as well as education of healthcare staff during this period influenced current functioning of clinical ethics consultation in the transition countries. (shrink)

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in (...) a 10-year period of patient advocates’ activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate’s work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients’ advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics in the Twenty-First Century: Why We Should Pay Attention to Eighteenth-Century Medical EthicsLaurence B. McCullough (bio)Those of us who work in the field of bioethics tend to think that, because the word “bioethics” is new, so too the field is new in all respects, but we are not the first to do bioethics. John Gregory (1724–1773) did bioethics just as we do (...) it, at least two centuries before we thought to do it (Gregory 1772). He deployed philosophical methods as sophisticated as our own. Indeed, Gregory took up the very best moral philosophy available to thinkers of the Scottish Enlightenment, namely, David Hume’s moral philosophy and its core concept of sympathy. Gregory also responded in a conceptually powerful and clinically applicable way to the problems of his time, just as we do. I want here to outline Gregory’s accomplishment and to identify some aspects of its importance for bioethics in the twenty-first century.Gregory’s “Problem List”Gregory wrote his medical ethics as a response to the then current state of medicine in Britain. We now follow Gregory in our writing of bioethics and clinical ethics in response to the problems of our time. A great deal that we now take for granted did not then exist. 1There was not, as there is now, any uniform pathway into medicine. Nor did there exist universal licensure. The Royal Colleges did attempt to assert, but failed to achieve, monopoly control of medical practice. The concepts of health and disease were themselves contested and therefore competed for their success in the market place. There was a marked oversupply of practitioners who competed fiercely—very fiercely indeed—in the medical market place for their concepts of health and disease, their treatments, and therefore their livelihoods. Patients had their own concepts of health and disease, engaged in “self-physicking” or self-care, and often traded physician’s prescriptions.Medicine exhibited little scientific discipline in its accounts of disease and in determining the efficacy of treatments, a fact that Gregory (1743) laments as a [End Page 329] medical student. There was no marked improvement when he began to give his medical ethics lectures nearly a quarter of a century later. Treatments failed as often, perhaps more often, than they succeeded in benefiting patients. The sick usually sought out the help of a physician after trying self-physicking.Physicians, Gregory taught, could not hope to control human biology, though they could aim to manage its processes well. When nature underresponds to disease the physician should assist her processes; when nature overresponds, the physician should tamp down nature’s responses, to lessen their “violence”—in both cases always attentive to the limits of medicine’s capacities in treating disease.Physicians attended the well-to-do sick at home, and the sick person summoned and dismissed physicians, surgeons, or apothecaries at will. A physician therefore might find himself—no women had yet been admitted to the ranks of university-trained physicians—summoned before, after, or simultaneously with a competitor, with his concepts and diagnosis and treatment put to the acid test. In this setting, there existed only a patient-physician relationship, not a physician-patient relationship.Physicians left off the care of dying patients, a practice that was made a matter of duty by Friederich Hoffmann (1749). One would suffer punishing economic consequences if one had a high mortality rate. Better, then, to label the patient incurable, withdraw, and turn matters over to clergy. Gregory attacks this practice as intellectual fraud and calls for the physician to continue to attend the dying. Indeed, he says, “It is as much the business of a physician to alleviate pain, and to smooth the avenues of death, when unavoidable, as to cure diseases” (Gregory 1772, p. 35). He does not explicitly address what we now call physician-assisted suicide; neither does he condemn it, and he is quick to condemn some things—e.g., sexual abuse of female patients or “sporting” with patients in the Royal Infirmary by using experiments as the first line of treatment.The Royal Infirmary was established to care for the deserving, working poor, who received free care... (shrink)

This book offers an in-depth analysis of the wide range of issues surrounding "passive euthanasia" and "allow-to-die" decisions. The author develops a comprehensive conceptual model that is highly useful for assessing and dealing with real-life situations. He presents an informative historical overview, an evaluation of the clinical settings in which treatment abatement takes place, and an insightful discussion of relevant legal aspects. The result is a clearly articulated ethical analysis that is medically realistic, philosophically sound, and legally (...) viable. (shrink)

Advances in medical technology and information have facilitated clinical practices that favourably affect the success rates of treatment for diseases. Regenerative medicine has been the focus of the recent medical agenda, to the extent of fundamentally changing treatment paradigms. Stem cell practices, their efficacy, and associated ethical concerns have been debated intensively in many countries. Stem cell research is carried out along with the treatment of patients. Thus, various groups affected by the practices inevitably participate in the (...) discussions. In addition to discussions based on avoiding any harm, providing benefits and respecting personal autonomy and justice, problems arise owing to the lack of legal regulations for stem cell research and practice. The dimensions of the problems vary in the developing countries, with widespread use of advanced medical technology but with lack of sources allocated for healthcare, dominance of paternalistic physician–patient relationships and failure to achieve a sufficient level of awareness of patients’ rights. This article discusses the current situation of stem cell practices within the context of regenerative medicine in Turkey and ethical concerns about some of the legal regulations, such as the Regulation for Umblical Cord Blood Banking and Guidelines for Non-embryonic Stem Cell Study for Non-clinical Purposes directing the research on this issue. (shrink)

The day-to-day work of clinical ethics consultants and healthcare ethics committees can easily become overly routine. Too much routine, however, comes with a risk that morally important practices will be reduced to mere bureaucratic formalities, while practitioners become desensitized to ethically significant distinctions between cases. Clinical ethics consultation and organizational ethics must be set within the broader social and cultural context of the healthcare environment. This practice requires looking beyond mere legal compliance and (...) the routinely false assumption that there are unambiguous ethical norms that easily govern clinical ethics and hospital policy formation. Together the essays in this issue of HEC Forum challenge readers to rethink taken-for-granted assumptions regarding patient care, physician obligation, clinical ethics consultation, and organizational ethics. (shrink)

The problem of ethics in medical care as seen from the bioengineering results from the almost incredible technological achievements based on scientific research: On the one hand there is inadequate handling of technology and fear on the part of the patient; on the other hand there is admiration on the part of the physicians and the nursing staff. This article will survey the points of criticism concerning ethical behavior and will present and evaluate general problems of mechanization in (...) medical care. General phenomena of human interaction, and especially problems related to medical care, will be discussed. It will be necessary to develop clinical medical technology, aiming primarily at realizing the patient's concern. After analyzing these concerns, it is necessary for the clinical medical engineer to develop an invisible technology. Criteria for such an invisible technology (function, design, automatic control, methods of implantation, whether chronic application is necessary) are being demonstrated by particular devices (artifical heart, functional electro-stimulation, diaphragmatic pace-maker). (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the (...) most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

Unlike bioethics mediators who are employed by healthcare organizations as outside consultants, mediators who are embedded in an institution must be authorized to chronicle a clinical ethics consultation (CEC) or a mediation in a patient’s medical chart. This is an important privilege, as the chart is a legal document. In this article I discuss this important part of a bioethics mediator’s tool kit in my presentation of a case illustrating how bioethics mediation may (...) proceed, and what this approach using both bioethics and mediation may add. (shrink)

With the rapid development of biotechnology, the physician is now more able to keep a patient's life going indefinitely on a life support system. The question of whether we should switch off the machine often arises when, according to the medical prognosis, there is no hope of recovery, or in a no-win situation where you are 'damned if you do and damned if you don't'. In a case which seems without hope, the dilemma of whether to prolong a life (...) or let it go disturbs many people, including health professionals as well as the family of the patient. In this painful situation, an ethics consultant who has received intensive training can help the concerned parties to arrive at what may be the best decision. How do Asians, especially those living in countries influenced by Confucian teachings, reach their answers? Three aspects are usually considered: (1) motivation and situation; (2) reasonableness and propriety; and (3) lawfulness and legality. More specifically, three questions are deliberated, as follows. (1) Where an action has already been taken, what motivated it and in what situation? Or, where a decision has still to be made, what should motivate it, and what are the relevant features of the situation? (2) Was the attempted resolution of the dilemma, or is its prospective resolution, reasonable and in accordance with traditional principles of ethical behaviour? (3) Was the action taken lawful, or would the intended action be lawful? This approach to finding an answer has been practised for centuries in Confucian society. But what is legal may not always be reasonable, what is reasonable may not always be compassionate, and what is compassionate may not always be either legal or reasonable. Principles to guide decision-making are therefore called for. This article, written by Michael Cheng-tek Tai in collaboration with Donald Hill, discusses the Confucian method of solving a problem and examines its principal features and how they are applied in ethics consultations. The article is followed by a series of questions and answers and a commentary by Donald Hill. (shrink)

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by (...) the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation. (shrink)

Leading paradigms of clinical ethics consultation closely follow a biomedical model of care. In this paper, we present a theoretical reflection on the underlying biomedical model of disease, how it shaped clinical practices and patterns of ethical deliberation within these practices, and the repercussions it has on clinical ethics consultations for patients with chronic illness. We contend that this model, despite its important contribution to capturing the ethical issues of day-to-day clinical ethics deliberation, (...) might not be sufficient for patients presenting with chronic illnesses and navigating as “lay experts” of their medical condition(s) through the health care system. Not fully considering the sources of personal knowledge and expertise may lead to epistemic injustice within an ethical deliberation logic narrowly relying on a biomedical model of disease. In caring “for” and collaboratively “with” this patient population, we answer the threat of epistemic injustice with epistemic modesty and humility. We will propose ideas about how clinical ethics could contribute to an expansion of the biomedical model of care, so that important aspects of chronic illness experience would flow into clinical-ethical decision-making. (shrink)

Healthcare policy and academic literature have promoted improving the transitional care of young people leaving child and adolescent mental health services. Despite the availability of guidance on good practice, there seems to be no readily accessible, coherent ethical analysis of transition. The ethical principles of non-maleficence, beneficence, justice and respect for autonomy can be used to justify the need for further enquiry into the ethical pros and cons of this drive to improve transitional care. The objective of this systematic review (...) was therefore to systematically search for existing ethical literature on child- to adult-orientated health service transitions and to critically appraise and collate the literature, whether empirical or normative. A wide range of bioethics, biomedical and legal databases, grey literature and bioethics journals were searched. Ancestral and forward searches of identified papers were undertaken. Key words related to transition, adolescence and young adulthood, ethics, law and health. The timeframe was January 2000 to at least March 2016. Titles, abstracts and, where necessary, full articles were screened and duplicates removed. All included articles were critically appraised and a narrative synthesis produced. Eighty two thousand four hundred eighty one titles were screened, from which 96 abstracts were checked. Forty seven full documents were scrutinised, leading to inclusion of two papers. Ancestral and forward searches yielded four further articles. In total, one commentary, three qualitative empirical studies and two clinical ethics papers were found. All focused on young people with complex care needs and disabilities. The three empirical papers had methodological flaws. The two ethical papers were written from a clinical ethics context rather than using a bioethical format. No literature identified specifically addressed the ethical challenges of balancing the delivery of transitional care to those who need it and the risk of pathologizing transient and self-limited distress and dysfunction, which may be normal during adolescence. There is very little research on ethical aspects of transitional care. Most existing studies come from services for young people with complex care needs and disabilities. There is much scope for improvement in the amount and quality of empirical research and ethical analysis in this area. (shrink)

Continuous sedation until death is an increasingly common practice in end-of-life care. However, it raises numerous medical, ethical, emotional and legal concerns, such as the reducing or removing of consciousness, the withholding of artificial nutrition and hydration, the proportionality of the sedation to the symptoms, its adequacy in actually relieving symptoms rather than simply giving onlookers the impression that the patient is undergoing a painless 'natural' death, and the perception that it may be functionally equivalent to euthanasia. This (...) book brings together contributions from clinicians, ethicists, lawyers and social scientists, and discusses guidelines as well as clinical, emotional and legal aspects of the practice. The chapters shine a critical spotlight on areas of concern and on the validity of the justifications given for the practice, including in particular the doctrine of double effect. (shrink)

I support Abram Brummett’s contention that there is a need for secular clinical ethics to acknowledge that various positions typically advocated for by ethicists, concerning bedside decision-making and broader policy-making, rely upon metaphysical commitments that are not often explicit. I further note that calls for “neutrality” in debates concerning conscientious refusals to provide legal health care services—such as elective abortion or medical aid-in-dying—may exhibit biases against specific metaphysical claims regarding, for instance, the ontological and moral status (...) of fetuses or the valuing of the phenomena of life, suffering, and dying/death, as constitutive of medicine’s internal morality as a profession. I conclude that there is an operative distinction between metaphysical views founded essentially upon religious tenets and those founded upon rationally defensible premises. (shrink)

The American Medical Association enacted its Code of Ethics in 1847, the first such national codification. In this volume, a distinguished group of experts from the fields of medicine, bioethics, and history of medicine reflect on the development of medical ethics in the United States, using historical analyses as a springboard for discussions of the problems of the present, including what the editors call "a sense of moral crisis precipitated by the shift from a system (...) of fee-for-service medicine to a system of fee-for-system medicine, better known as 'managed care.'" The authors begin with a look at how the medical profession began to consider ethical issues in the 1800s and subsequent developments in the 1900s. They then address the sociological, historical, ethical, and legal aspects of the practice of medicine. Later chapters discuss current and future challenges to medical ethics and professional values. Appendixes display various versions of the AMA's Code of Ethics as it has evolved over time. Contributors: George J. Annas, J.D., M.P.H., Arthur Isak Applbaum, Ph.D., Robert B. Baker, Ph.D., Chester R. Burns, M.D., Ph.D., Arthur L. Caplan, Ph.D., Alexander Morgan Capron, J.D., Christine K. Cassel, M.D., Linda L. Emanuel, M.D., Ph.D., Eliot L. Freidson, Ph.D., Albert R. Jonsen, Ph.D., Stephen R. Latham, J.D., Ph.D., Susan E. Lederer, Ph.D., Florencia Luna, Ph.D., Edmund D. Pellegrino, M.D., Charles E. Rosenberg, Ph.D., Mark Siegler, M.D., Rosemary A. Stevens, Ph.D., Robert M. Tenery, Jr., M.D., Robert M. Veatch, Ph.D., John Harley Warner, Ph.D., Paul Root Wolpe, Ph.D. (shrink)

Bioethics: Legal and Clinical Case Studies is a case-based introduction to ethical issues in health care. Through seventy-eight compelling scenarios, the authors demonstrate the practical importance of ethics, showing how the concerns at issue bear on the lives of patients, health care providers, and others. A range of central topics are covered, including informed consent, medical futility, reproductive ethics, privacy, cultural competence, and clinical trials. Each chapter includes a selection of important legal (...) cases as well as clinical case studies for critical analysis. The case studies are often presented as moral dilemmas, and are conducive to rich discussion. A companion website offers a curated collection of relevant legal precedents as well as additional case studies and other resources. (shrink)

Respect for confidentiality is firmly established in codes of ethics and law. Medical care and the patients' trust depend on the ability of the doctors to maintain confidentiality. Without a guarantee of confidentiality, many patients would want to avoid seeking medical assistance The principle of confidentiality, however, is not absolute and may be overridden by public interests. On some occasions (birth, death, infectious disease) there is a legal obligation on the part of the doctor to disclose (...) but only to the appropriate authorities. Permissible disclosure can be granted by the patients' consent, for example, for the purpose of insurance they may wish to take out. Moreover, there are some ambivalent situations (such as criminal acts, or notification of sexual partner in case of a patient with AIDS) for which Greek law does not include relevant provisions, and the Codes of Medical Ethics do not offer clear guidelines. Therefore, the Greek doctor is called to estimate the situation and assume full responsibility for his decision. Finally, new considerations have arisen in the context of the recent advances in the field of telemedicine and electronic archiving. The paper discusses the current situation and legislation in Greece. (shrink)

As Steve Kaminshine said in his comments at the symposium honoring Charity Scott, I was recruited to come to Georgia State University as a “Law and Bioethics” scholar who had spent more than sixteen years shuttling between an office in a hospital and another in a law school. But when I first visited Georgia State Law, I did not know that more than ten years earlier Charity Scott had spent the better part of an academic year living and breathing (...) clinical ethics at Grady Memorial Hospital.1 Because of her usual habit of immersion in all learning experiences, in that year Charity gained more insight into how hospitals work and how physicians behave when they are knee deep in their professional milieu of life and death decision-making than many full-time bioethics academics do in a career. For the rest of her career Charity kept one foot well planted in the medical context, as an advisor in problems of research ethics, as a teacher in her own medical-legal partnership structured around real-life clinical problems, and as an ethical analyst who could never be accused of mouthing a mantra of phrases, the “vacuous incantation of abstract principles”2 that might pass for bioethics discourse in some circles. (shrink)

This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC’s benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization (...) and service purpose and operation and open-ended questions about the benefits and problems of initiating CEC. The questionnaire comprised the presence/absence of an ethics committee, CEC services and membership when services were implemented, users, and the number of cases handled since inception. In addition, the respondents also provided their impressions of the CEC system’s impact on their hospital by describing (a) the benefits of CEC services and (b) the ineffectual or harmful aspects of the CEC system. Qualitative data were examined using qualitative content analysis to determine the impact of establishing a CEC and the difficulties of practice. One hundred twenty-five questionnaires were returned from either the chair of the ethics committee or clinical ethics committee in teaching hospitals. Of these, 90 (72%) reported they provided CEC services. Additionally, 36 respondents (34.6%) reported that their existing research and clinical ethics committees had conducted CEC services, and 35 (33.7%) reported having a newly established clinical ethics committee conducting CEC services. Three positive effects of establishing and four challenges in managing CEC were also identified. (shrink)

Gene therapy research and its clinical application raise a large number of ethical, legal, and social questions. Many of these are discussed in Nordgren's anthology. The contributions come from a number of different disciplines, including bioethics, genetics, social science, and theology. The book is divided into five main sections (following a short introduction): scientific aspects of gene therapy; the history of, and prospects for, gene therapy; conceptual issues; gene therapy in a German and Japanese context, and (...) a section on the uses of gene therapy in relation to, for example, testing and screening. The contributions are quite diverse and mostly well worth reading. From the perspective of medical ethics the contributions by LeRoy Walters, Eric Juengst, Karen Lebacqz, Nikolaus Knoepffler, and Christian Munthe are of particular interest. Walters's contribution focuses in part on the issue of …. (shrink)

Evaluating clinical ethics support services has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a (...) first step, we introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS. (shrink)

Beauchamp and Childress have performed a great service by strengthening the principle of respect for the patient's autonomy against the paternalism that dominated medicine until at least the 1970s. Nevertheless, we think that the concept of autonomy should be elaborated further. We suggest such an elaboration built on recent developments within the neurosciences and the free will debate. The reason for this suggestion is at least twofold: First, Beauchamp and Childress neglect some important elements of autonomy. Second, neuroscience itself needs (...) a conceptual apparatus to deal with the neural basis of autonomy for diagnostic purposes. This desideratum is actually increasing because modern therapy options can considerably influence the neural basis of autonomy itself.Sabine MNeuroScienceAndNorms: Ethical and Legal Aspects of Norms in Neuroimaging at Bonn University Hospital, Germany. Her main research interests are in neuroethics. She is coauthor of three German books about neuroethics and bioethics.Henrik Walter, M.D., Ph.D., is Full Professor of Medical Psychology at the University of Bonn, Germany, and vice-director of the Department of Psychiatry and Psychotherapy at the University Clinic of Bonn. He is author of Neurophilosophy of Free Will and editor of the book From Neuroethics to Neurolaw?. His research fields are biological psychiatry, cognitive neuroscience, neuroimaging, neurophilosophy, and neuroethics. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: (...) an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. (shrink)

Clinical ethics consultants respond to a multitude of issues, ranging from the cognitive to the emotional. As such, ethics consultants must be prepared to analyze as well as empathize. And yet, there remains a paucity of research and training on the interpersonal and emotional aspects of clinical ethics consultations—the so-called skills in “advanced ethics facilitation.” This article is a contribution to the need for further understanding and practical knowledge in the emotional aspects (...) of ethics consultation. In particular, I draw attention to defense mechanisms: what they are, why they exist, and how we might work with them in the setting of ethics consultation. (shrink)

Medical professionals providing humanitarian aid in times of crisis face complicated ethical and clinical challenges. Today, humanitarian aid is given in accordance with existing guidelines developed by international humanitarian organizations and defined by international law. This paper considers the ethical aspects and frameworks of an atypical humanitarian project, namely one that provides medical support through an Israeli civilian hospital to Syrian Civil War casualties. We explore new ethical questions in this unique situation that pose a serious (...) challenge for the medical community and conventional ethical norms, a challenge Israeli medical staff meet on a daily basis. Before discussing the ethical challenges, we give a description of the project and its unique status. (shrink)

The convergence of complementary and alternative medicine (CAM) and evidence-based medicine (EBM) is a prominent feature of healthcare in western countries, but it is currently undertheorised, and its implications have been insufficiently considered. Two models of convergence are described – the totally integrated evidence-based model (TI) and the multicultural-pluralistic model (MP). Both models are being incorporated into general medical practice. Against the background of the reasons for the increasing utilisation of CAM by the public and by general practitioners, TI-convergence (...) is supported and MP-convergence is rejected. MP-convergence is epistemologically and clinically incoherent, and it cannot be regulated. It is also inconsistent with developments in the legal determination of the standard of care for both diagnosis/treatment and disclosure. These claims concerning MP-convergence are justified by the fact that science is not a member of the group of perspectives or world-views which postmodernism treats as equally valid, and this is especially important for healthcare. (shrink)